HEMO-CATH SILICONE DOUBLE LUMEN CATHETER— 510(k) K890029

Name: FDA 510(k) clearance K890029
Creator: U.S. Food and Drug Administration
Published: 1989-04-17

Substantially Equivalent

Medical Components, Inc.

FDA 510(k) clearance K890029 for HEMO-CATH SILICONE DOUBLE LUMEN CATHETER, Substantially Equivalent on 1989-04-17. Applicant: Medical Components, Inc.. Device class: 2.

Clearance details

Applicant: Medical Components, Inc.
Product code: Code LFJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1989-01-04
Decision date: 1989-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

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K913468 — ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY1994-03-24
K920634 — SPLITTABLE SHEATH INTRODUCER SET1994-01-14

More clearances from Medical Components, Inc.

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K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter2025-08-12
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K132880 — MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE2014-01-08
K131687 — 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET2013-08-16
K130687 — 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER2013-08-15

Recalls naming K890029

K-number listed on FDA's recall record

Z-1083-2015 — Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). Intended uses: To attain long-term vascular access for hemodialysis and apheresis. The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC¿ CT catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The Peripherally Inserted Central Vein Access Catheters are designed for Long or Short- Term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.Class II·Terminated·Medical Components, Inc dba MedComp·20150121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K890029.

Data sourced from openFDA. This site is unofficial and independent of the FDA.